The Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing resource for small and large molecule therapeutics for clinical trials. It provides services for drug discovery, process research, and the development and early clinical manufacturing of active pharmaceutical ingredients (API) that meet the requirements of the Food and Drug Administration.
Thanks to its significant range of capabilities, the CGSF plays a key role in bridging basic science and translational medicine at City of Hope and is a key component of the Developmental Cancer Therapeutics Program.
The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and in Phase I and Phase II clinical trials.
The CGSF provides internal and external investigators with a regulatory-compliant, cost-effective route towards bringing promising therapeutics to the clinic.
cGMP Grade API Manufacturing
The manufacturing suites at the CGSF are designed to accommodate gram-to-kilogram production of cGMP-grade, small-molecule, biopolymer (peptides, siRNA-aptamers, DNA-peptide hybrids) and nano material API in support of Phase I and Phase II clinical trials. Adherence to cGMP (current good manufacturing practices) is essential in ensuring the quality and integrity of manufactured API.
Integrated Quality Control
An on-site quality control unit is committed to providing excellent service surrounding the testing and release of manufactured API with strict adherence to requirements set forth by the Food and Drug Administration.
A team of synthetic and analytical chemists provide an array of services and support that continue to bring benchtop discoveries to the clinic. Such discoveries include:
- Route selection and optimization
- Process development and scale-up
- Synthesis of good laboratory practices (GLP)
- API for toxicology
- Synthesis and characterization of metabolites, impurities, and reference standards